Kornimate/medical-research-clean huggingface dataset:
bougie sleeve trial

Conditions: Morbid Obesity

Summary: staple-line leak is the most frequent and incapacitating complication after laparoscopic sleeve gastrectomy (lsg). the aim of this prospective randomized trial is to compare the staple-line leak rate after lsg according to the use of a standard bougie calibre (34, 36 or 38 fr) or 48-fr, assuming that a higher diameter is correlated with a lower risk of leak, without lowering long-term weight loss.

laparoscopic sleeve gastrectomy (lsg) has become an increasing bariatric procedure. the most common complication is gastric leak from the staple line, observed in approximately 3% of cases, and can result in long and incapacitating treatment. the diameter of the bougie used to calibrate the remnant stomach could impact the rate of gastric leak, a higher diameter being correlated with a lower risk of leak, without lowering long-term weight loss. the aim of this prospective randomized trial is to compare the outcomes of lsg according to the use of a standard care bougie calibre or 48-fr on postoperative gastric leak and mid-term weight loss.

Eligibility criteria:
inclusion criteria: * patients between 18 and 70 years * sleeve gastrectomy as a primary bariatric procedure * body mass index (bmi) \> 40 kg/m² or \> 35 kg/m² associated with at least one comorbidity susceptible to improve after surgery (including arterial hypertension, obstructive sleep apnea syndrome and other severe respiratory disorders, severe metabolic disorders, particularly type 2 diabetes, incapacitating osteo-articular disorders, non alcoholic steatohepatitis) * decision for intervention after multidisciplinary discussion * written informed consent exclusion criteria: * previous upper abdominal surgery (cholecystectomy excepted) * asa (american society of anesthesiologists) score \> 3 * ongoing pregnancy or breast feeding * esophagus pathology or disorder (esophageal varices, esophageal diverticula, esophageal tumors, esophageal strictures) * coagulation disorder * patient not covered by social security service and patient on ame * patient under legal guardianship and trusteeship * patient with known silicon allergy (calibration bougie contains medical silicon) * more generally, all other contraindications to the use of esophageal bougie mid-tube that have been the subject of a scientific paper or have been identified by the practitioner or practitioners

Keywords: obesity bariatric surgery sleeve gastrectomy staple-line leak bougie calibration
clinical study of umbilical cord mesenchymal stem cells in the treatment of type 2 diabetic nephropathy

Conditions: Type 2 Diabetes With Renal Manifestations

Summary: the study was a 48-week multicenter, randomized, double-blind, placebo-controlled trial that included 8 weeks of pre-screening and lifestyle education, 32 weeks of treatment, and 16 weeks of follow-up.to observe the efficacy and safety of umbilical cord mesenchymal stem cell infusion in chinese patients with type 2 diabetic nephropathy who received traditional hypoglycemic therapy.

the study was a 48-week multicenter, randomized, double-blind, placebo-controlled trial that included 8 weeks of pre-screening and lifestyle education, 32 weeks of treatment, and 16 weeks of follow-up.we plan to recruit 54 subjects，which were divided into experimental group and control group. the volunteers of the experimental group will be given peripheral intravenously a dose of 1.5\*10\^6/kg human umbilical cord mesenchymal stem cell (huc-msc) at 0,8,16,24,32 week. the control group will be given the same dose of saline. then centralization visit was conducted every 8 weeks until the 48th week.the primary end points include estimated glomerular filtration rate and urinary albumin creatinine ratio(uacr). the secondary end points include hba1c,plasma insulin and c-peptide, and insulin dose.

Eligibility criteria:
inclusion criteria (in brief): * type 2 diabetes mellitus * diabetes duration≤20 years * 18.5kg/m\^2 ≤ bmi\< 30 kg/m\^2 * 7.5%≤hba1c≤10% * uacr≥30mg/gcr * egfr ≥45/milliliter/1.73m\^2 exclusion criteria (in brief): * type 1 diabetes mellitus * tumor history * other causes of chronic kidney disease * abnormal liver function

Keywords: human umbilical cord mesenchymal stem cells type 2 diabetic nephropathy
market research - acceptability study for a range of mct products

Conditions: Ketosis; Epilepsy; Ketogenic Diet; Fatty Acid Oxidation Disorder; Malabsorption

Summary: this is a market research, observational study to evaluate the tolerability and acceptability of mct supplements for young children and young people with intractable epilepsy, glut-1 or pdhd from 3 years to adulthood. patients with a confirmed diagnosis of a fatty acid oxidation disorder, which requires a specialist diet including mct will be included in this study


Eligibility criteria:
inclusion criteria: * diagnosis of epilepsy or a fatty acid oxidation disorder requiring a ketogenic or a specialist diet as part of their treatment, which includes mct. * subjects who are new to or already taking an mct oil and are willing to try each of the 3 study products for 7 days each. 21 days taking product with 2 days between new product trialled. * patients aged 3 years of age to adulthood. * written informed consent obtained from patient or parental caregiver. exclusion criteria: * presence of serious concurrent illness * investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements * participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study. * any patients having taken antibiotics over the previous 2 weeks leading up to the study. * patients less than 3 years of age.
the dental care revolution: health education using ai or humanized counseling on plague control and periodontal treatment outcome in patients with periodontal disease

Conditions: Periodontal Diseases

Summary: the aim of this study was to evaluate the long-term effectiveness of an ai dental monitoring intervention on patients' periodontal disease, preventive behaviors and motivation. this randomized controlled trial included experimental group: ai group (eg-a), ai-humanized group (eg-b) and control group(cg), respectively. the eg-a and eg-b received ai dental monitoring intervention by taking mouth image at home once a week for six month. baseline and follow-up surveys were used to collect the data in oral health related quality of life,periodontal parameters, periodontal preventive behaviors and motivation.

a randomized experimental design was used. patients with periodontal disease whose aged 35-65 years were recruited through department of periodontics in kaohsiung medical university hospital. each group was expected for 100 per group, patients will be randomized into each group. g\*power (version 3.1.9.4) was used for power analysis. all patients will underwent periodontal examination at baseline and at 1-month, 3-month, 6-month follow-ups. each patients will be diagnosed periodontal disease by dentist and have more than 16 functional teeth. each patients will completed the questionnaire at baseline and at 1-month, 3-month and 6-month follow-up.

Eligibility criteria:
inclusion criteria: * age between 35-65 years old * diagnosed periodontal disease by dentist (comprehensive periodontal treatment project) * more than 16 functional teeth exclusion criteria: * have received periodontal treatment within 3 months * patient has disease related to periodontal disease (ex. drug-related excessive gum growth or blood clotting problems, pregnancy, mental illness) * disability patients

Keywords: periodontal disease artificial intelligence (ai) ohrqol
mobile application for patient engagement and physician-directed remote management of heart failure

Conditions: Heart Failure

Summary: the engage-hf mobile application tracks three key features over time: (1) heart failure health status, (2) vital signs (e.g., blood pressure, heart rate) and weight, and (3) the quality of heart failure medication therapy. helping patients understand how these characteristics interact and change over time may improve their ability to understand and manage heart failure. in this study, the investigators aim to evaluate whether the engage-hf mobile application, by facilitating the behavior change strategies of self-monitoring and feedback, and a clinician-facing dashboard, improves the optimization of heart failure guideline-directed medical therapies (gdmt) and quality of life. an optional sub-study of cognitive function will invite all eligible participants enrolled in the main study to participate.


Eligibility criteria:
inclusion criteria: * diagnosis of heart failure * last left ventricular ejection fraction within 2 years \< 50% based on echocardiogram, mri, ct, or nuclear perfusion and, if no ejection fraction documented, then clinical documentation of heart failure with reduced ejection fraction * currently admitted with upcoming discharge or discharged from hospital within the prior 4 weeks * at least two eligible heart failure therapies (guideline-recommended bb, rasi, mra, or sglt2i) not yet initiated or at \< 50% of target dose at time of enrollment exclusion criteria: * receives dialysis * inotropic therapy after hospitalization * history of a prior solid organ transplant or actively listed on heart transplant waiting list * history of left ventricular assist device implantation * cardiac amyloidosis * currently pregnant or intends to become pregnant during the study period * life expectancy estimated less than 6 months related to cardiac or non-cardiac comorbidities as per investigator's judgment * actively enrolled in hospice or comfort care * currently participating in an investigational device or drug study or having participated in such a study 30 days prior to screening * subject without a compatible smartphone * subject not proficient with written and spoken english * any other disorder or condition that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion * participant has diminished decision-making capacity * admitted to or planned discharge to a skilled nursing facility or rehabilitation facility (acute or subacute)

Keywords: medication optimization
study of cediranib plus cisplatin plus capecitabine/s-1 in japanese gastric cancer patients

Conditions: Gastric Cancer

Summary: the primary objective of the study is to assess the safety and tolerability of cediranib in combination with cisplatin plus a fluoropyrimidine (capecitabine or s-1) in japanese patients with previously untreated locally advanced or metastatic unresectable gastric cancer (gc).


Eligibility criteria:
inclusion criteria: * histological or cytological confirmation of gastric adenocarcinoma (including the gastric cardia and esophagogastric junction) * having locally advanced or metastatic gastric cancer for which they must have received no prior systemic therapy for locally advanced disease. previous gastrectomy, neoadjuvant and adjuvant therapy received \> 6 months ago are acceptable * having a mild symptom in ordinal daily lives including walking and simple labour or works in the sitting position exclusion criteria: * a history of poorly controlled hypertension or resting bp \> 150/100 mmhg in the presence or absence of a stable regimen of anti-hypertensive therapy or patients who are requiring maximal doses of calcium channel blockers to stabilize bp * significant haemorrhage (\> 30 ml bleeding/episode in previous 3 months) or haemoptysis (\> 5 ml fresh blood in previous 4 weeks) * arterial thromboembolic event (including ischemic attack) in the previous 12 months

Keywords: gastric cancer japanese phi safety and tolerability cediranib in combination with cisplatin plus a fluoropyrimidine cediranib capecitabine s-1 cisplatin untreated locally advanced or metastatic unresectable gastric cancer (gc)
enhancing behavior and brain response to visual targets using a computer game

Conditions: Neurodevelopmental Disorders

Summary: participants will play a computer game that is controlled by their gaze patterns and designed to direct attention their attention to specific on-screen targets. visual attention to targets will be rewarded. both visual behavior and brain response will be recorded during game play. it is hypothesized that that, over the course of the game, relative to baseline, participants will show (a) increased looking to targets, (b) decreased response time to targets, and (c) enhanced, more efficient neural response to visual cues. it is hypothesized that clinical variability will associate with visual attention and brain response.


Eligibility criteria:
inclusion criteria: * able to participate in an eye-tracking experiment * able to participate in an eeg experiment exclusion criteria: * sensory or physical impairment that would preclude completion of protocol * participants taking prescription medications that may affect cognitive processes * participants reporting significant head trauma or history of seizures
substance use disorder, brain and behavioral regulation

Conditions: Substance Use Disorders

Summary: the proposed project seeks to explore the effects of a neuroregulation paradigm named z-score quantitative electroencephalogram (qeeg) guided sloreta neurofeedback (zqln) on optimizing brain electrophysiological activity and behavioral performance in a substance use disorder (sud) population whose primary drug of use is cocaine.

aim 1. measure the effects of zqln training on brain electrophysiological activation changes in sud patients. qeeg and event-related potentials procedures, recorded with a 19-channel digital eeg, will be conducted before and after 12-15 sessions of zqln to examine changes on dysregulated brain sites by inspection of the brain maps deviating brain areas sloreta brodmann areas voxels z-scores inside and outside the target window of -/+2 standard deviations. observation of p300 component latencies and amplitudes will be measured during a drug-cue gonogo paradigm. aim 2. measure the effects of zqln training on behavioral performance changes in sud patients. in the same participants of aim 1, pre and post behavioral performance (before and after 12-15 sessions of zqln) includes the assessment of attention and executive function, episodic memory, working memory language, and processing speed as measured by the nih toolbox cognitive domains battery scales. other behavioral variables include reaction times, omission, and commission errors in the drug-cue gonogo task.

Eligibility criteria:
inclusion criteria * age limit: 21 to 51 * cocaine as a primary drug of selection * be stable (such as not having reading or movement problems preventing them from using a computer keyboard or ipad). * have completed the first stage of treatment in the program (this first phase consists of the stabilization and detoxification period of the program participants) exclusion criteria * history of brain injury. * previous experience with neurofeedback training. * being unavailable to complete assessments.
comparison of vaginal misoprostol and dinoprostone prior to copper intrauterine device insertion in women delivered only by cesarean delivery

Conditions: IUD Pain

Summary: to compare the effect of vaginal dinoprostone versus vaginal misoprostol administered before the copper intrauterine device(iud) insertion in reducing iud insertion pain and the difficulty in inserting the iud in women delivered only by cesarean section.

long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. the intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. however, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.

Eligibility criteria:
inclusion criteria: * women delivered only by elective cesarean section and not received analgesics in the last 24 hours exclusion criteria: * contraindications to dinoprostone or misoprostol or iud insertion and allergy to study drugs.
s1 combined with cisplatin in treatment of recurrence/metastasis of escc open-label single center phase ii clinical study

Conditions: Esophageal Squamous Cell Carcinoma

Summary: assess the efficacy and safety of s1 combined with cisplatin in treatment of recurrence/metastasis of escc


Eligibility criteria:
inclusion criteria * joined the study voluntarily and signed informed consent form; * age 18-75 .presence of at least one index lesion measurable by ct scan or mri * recurrence/metastasis of esophageal carcinoma or gastroesophageal cancer confirmed by pathology * no radiotherapy, chemotherapy or other treatments prior to enrollment * ps ecog 0-1 * life expectancy of more than 3 months * anc≥2×109/l，plt≥100×109/l，hb≥90g/l * cr≤1.0×unl * tbil≤1.25×unl； alt/ast≤2.5×unl，with hepatic metastases alt/ast≤5.0×unl；akp≤2.5×unl exclusion criteria: * there is radical cure of the cancer * uncontrolled chronic diarrhea and esophageal obstruction * neurological or mental abnormalities influence of cognitive ability include central nervous system metastases * severe complication(s), e.g.,uncontrolled active infection,myocardial infarction,hypertension,arrhythmia,stenocardia * patient who has metastasis except cured skin basal cell carcinoma and carcinoma in situ of cervix * accept other antitumor therapy •female patients during their pregnant and lactation period, or patients without contraception

Keywords: escc
health practice of hemophilia patiente care during pregnancy, delivery and newborn children

Conditions: Hemophilia

Summary: prenancy and specialy delivery for hemophilia mother and her children possibly hemophilia is risked. diagnostical of hemophilia pregnan is the first difficulty but patients with hemorrhagic menstruation without etiology known, hemorrhagic complication during a chirurgical procedure or during previously pregnancy currently are examine in haemostasis consultation. none french recommendation specifie for health practice of these hemophilia patients exists. however, anglo-saxon recommendations are published in 2011. the objective of this study is to realize a french investigation of health practice about hemophilia care of these patients and to compare them with the english reference table.


Eligibility criteria:
inclusion criteria: * adult * hemophilia a or b * pregnancy between 2014 and 2016 exclusion criteria: - opposition

Keywords: hemophilia pregnant hemophilia delivery hemophilia children
medical polypectomy and predictors of response

Conditions: Nasal Polyps

Summary: this is the first randomized parallel group clinical trial looking at oral prednisolone induced medical nasal polypectomy followed by maintenance on topical steroid therapy in patients with nasal polyposis. this study also looks at the effect of aspirin sensitivity and the factors linking nasal polyps with asthma. we have also taken baseline measurements of a variety of blood, surface and biopsy markers to assess for potential to predict steroid response. finally, the still unchartered link between nasal polyps and asthma will be explored by measuring staphylococcal superantigens in serum before and after treatment.


Eligibility criteria:
inclusion criteria: * male or female * 18-75 years of age * bilateral nasal polyposis grade 2 and above * with or without asthma * with or without atopy or aspirin sensitivity * written informed consent exclusion criteria: * unilateral nasal polyposis * polypoid lesion suspicious of inverted papilloma, malignancy, wegeners granulomatosis, sarcoidosis * known or suspected hypersensitivity to fluticasone propionate or any other constituents of the investigational medicinal product (imp). * any clinically significant medical condition or abnormality, which, in the opinion of the investigator, might compromise the safety of the subject or which might interfere with the study. * significant (≥50%)septal deviation * inability to comply with the requirements of the protocol * females who are pregnant, lactating or planning to become pregnant.

Keywords: chronic rhinosinusitis nasal polyps oral steroid intranasal steroid medical polypectomy
dose escalation study of safety and tolerability of at-406 in patients with advanced solid tumors and lymphomas

Conditions: Cancer; Solid Tumors; Lymphoma; Malignancy

Summary: the purpose of this study is to determine the safety profile and the maximum dose of debio 1143 (at-406) that can be given to humans. this study is also designed to measure how much debio 1143 (at-406) gets into the blood stream (pharmacokinetics), and how debio 1143 (at-406) interacts with proteins related to cancer that the drug is targeted to affect (pharmacodynamics).

ascenta therapeutics, inc. is conducting a clinical trial of the compound debio 1143 (at-406), a small molecule second mitochondria-derived activator of caspase c (smac) mimetic. in vivo and in vitro studies have demonstrated that debio 1143 (at-406) induces cell death in several tumor models by inhibiting xiap (x linked iap), ciap-1 (cellular iap-1) and ciap-2 (cellular iap-2), thus releasing initiator and effector caspases to promote apoptosis. this protocol is a phase i, dose-escalation, open-label, multi-center study conducted in patients with advanced solid tumors and lymphomas to evaluate the safety, tolerability and pharmacology of debio 1143 (at-406) in humans when administered orally.

Eligibility criteria:
inclusion criteria: * histologically confirmed solid tumor or lymphoma; * locally advanced or metastatic disease for which no life prolonging therapy is available and no standard therapy is judged appropriate by the investigator; * eastern cooperative oncology group performance status ≤ 1; * adequate hematologic function as indicated by, anc ≥ 1,500/mm3, hgb \>9.0 g/dl, platelet count ≥ 100,000/mm3 * adequate renal and liver function as indicated by serum creatinine ≤ 1.0 x uln or creatinine clearance of \> 60 cc/min, serum albumin ≥ 3.0 gm/dl, total bilirubin \< 1.0 x uln, ast and alt ≤ 2.5 x uln ; alkaline phosphatase ≤2.5 x uln * negative hepatitis b and hepatitis c testing; * qtc interval ≤450ms. exclusion criteria: * radiation within 14 days of study entry, thoracic radiation within 28 days of study entry. patients who have received prior radiotherapy must have discontinued steroids for 14 days prior to study entry and be clinically stable; * not recovered to ≤ grade 1 toxicity from prior radiotherapy or chemotherapy agents; * use or requirement for use of aspirin or aspirin containing products with \>81 mg of aspirin per day; * history of gastrointestinal bleeding within 1 year; * history of diabetes mellitus requiring treatment with oral agents or insulin; * active rheumatoid arthritis, active inflammatory bowel disease, chronic infections, or any other disease or condition associated with chronic inflammation; * known or suspected wilson's disease, or other conditions that affect copper accumulation or regulation; * prior treatment with iap inhibitors.

Keywords: cancer solid tumors lymphoma smac mimetic iap inhibitor phase i dose escalation